FDA Registration
Active
🇸🇰 Slovakia
72200752
Reg #: 3024021261
·
FEI: 3024021261
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MDTGLOBAL, A.S.
- Registration Number
- 3024021261
- FEI Number
- 3024021261
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lomonosovova 2
- City
- Bratislava Bratislavsky
- Country
- SK
Regulatory Submissions
- 510(k) Number
- K151105
Owner / Operator
- Firm Name
- MDTGlobal, a.s.
- Operator Number
- 10085911
- Address
- Lomonosovova 2
- City
- Bratislava
- State
- Bratislavsky
- Postal Code
- 811 09
- Country
- SK
- Correspondent
- Richard Cunderlik
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-11-16 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2023-11-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-11-16 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2023-11-16 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-11-16 |
Proprietary Names
72200752
Establishment Types
Export Device to the United States But Perform No Other Operation on Device